Arthrex® AR-4030C-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00888867277663), received between Apr 27, 2021 and Aug 28, 2026 — classified as 5 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (39 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Failure to Advance; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498297 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE DURING INSERTION. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094444 ↗
• MalfunctionFeb 2, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-4030C-09 9 X 30 MM BIOCOMPOSITE INTERFERENCE SCREW BROKE. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE TIBIA WAS DRILLED WITH AN 8 MM DRILL, AND WHEN INSERTING THE 9X30 BIOCOMPOSITE SCREW, THE DRIVER MALFUNCTIONED, MADE A CRACKING SOUND, AND SPUN FREELY, CAUSING THE SCREW TO BREAK. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER BIOCOMPOSITE SCREW AND THE HANDLE FROM THE DRIVER INCLUDED IN THE MENISCUS SET WAS USED. THE PATIENT¿S BONE QUALITY WAS REPORTED AS GOOD, AND NO FRAGMENTS REMAINED. ADDITIONAL INFORMATION PROVIDED 14-JAN-2026: IT WAS FURTHER REPORTED THIS WAS DISCOVERED DURING AN ACL PROCEDURE WITH NO DELAY REPORTED OR ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237016 ↗
• MalfunctionNov 17, 2025Break; Break

  ON 10/30/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-4030C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 9 X 30 MM BROKE. THIS INCIDENT OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/06/2025: DURING AN ARTHROSCOPIC RIGHT KNEE PROCEDURE FOR ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION ON (B)(6) 2025, AN ISSUE OCCURRED DURING THE INSERTION OF THE INTERFERENCE SCREW. ALL DETACHED FRAGMENTS WERE IDENTIFIED AND SUCCESSFULLY RETRIEVED FROM THE PATIENT DURING THE PROCEDURE. THE CASE WAS COMPLETED USING A REPLACEMENT AR-4030C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW (9 X 30 MM). THE EVENT RESULTED IN A 10-MINUTE DELAY TO REMOVE THE BROKEN SCREW AND REQUIRED AN ADDITIONAL 10 MINUTES OF ANESTHESIA. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568961 ↗
• MalfunctionOct 30, 2025Insufficient Device Problem Information

  ARTHREX IMPLANT FASTTHREAD BIOCOMPOSITE SCREW 9X30 MM WITH REF# AR-4030C-09, LOT# 15295595 , EXP 06/30/2028 BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423851 ↗
• MalfunctionSep 19, 2025Break; Break

  ON 1ST SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4030C-09, FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 9 X 30 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE KNEE JOINT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4030C-09. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094931 ↗
• MalfunctionAug 19, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED DURING THE KNEE ARTHROSCOPY WITH RE-CONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT THAT THE SCREW COULD NOT BE SCREWED IN. PER COMPLAINT REPORTER, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839320 ↗
• MalfunctionAug 1, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE THREAD ON THE FRONT PART OF THE SCREW GOT WORN. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-4030C-10). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686637 ↗
• MalfunctionJul 28, 2025Break; Break

  ON 7TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-4030C-09, FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 9 X 30 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4330C-09. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637949 ↗
• MalfunctionJul 21, 2025Break; Break

  ON 27TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-4030C-09, FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 9 X 30 MM, THE FRONT END OF THE INTERFACE SCREW BROKE WHEN THE TIBIAL END WAS FIXED. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4030C-09. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22557321 ↗
• InjuryJul 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATE DW 26-AUG-2025: FURTHER INFORMATION WAS PROVIDED THAT THE SCREW WAS NOW REMOVED AND THE PATIENT HARM WAS RESOLVED WITH THE REMOVAL.

  Patient problems: Failure of Implant

  MAUDE report 22554233 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE IN HALF WHEN THE SURGEON TRIED TO FIXATE THE LIGAMENT. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509808 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE IN HALF WHEN THE SURGEON TRIED TO FIXATE THE LIGAMENT. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509649 ↗
• MalfunctionJul 2, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 07/11/2025: THIS OCCURRED DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. AN AR-4030C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW FROM LOT NUMBER 15173585 WAS USED. WHILE THREADING THE IMPLANT, THE DISTAL PORTION OF THE SCREW FRACTURED AND BROKE WITHIN THE BONE TUNNEL. THE SCREW REMAINED INSIDE THE PATIENT, AND ONLY THE LAST THREAD OF THE SCREW CAME OFF. TO COMPLETE THE CASE, THE SURGEON REINFORCED THE SCREW THAT SPLIT WITH AN AR-2324PSLC TILTING ANCHOR DEVICE IN THE FORM OF A POST. THE BONE SOCKET WAS PREPARED USING AN 8.0 MM FEMORAL DRILL (AR-1208L), A SCREWDRIVER AR-1996CD-1, AND A SCREWDRIVER HANDLE AR-1999. THE PATIENT WAS NOTED TO HAVE GOOD BONE QUALITY. THE EVENT RESULTED IN A 10-MINUTE DELAY, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. NO DRIVER MALFUNCTION WAS REPORTED, AND NO PATIENT HARM WAS NOTED FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22387121 ↗
• MalfunctionFeb 19, 2025Break; Damaged Thread; Break; Damaged Thread

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE THREAD OF THE DEVICE BROKE WHILE SCREWING. THE SCREW DID NOT MOVE SO THE SURGEON HAD TO PUNCH IT IN THE CORRECT POSITION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409688 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT PLASTIC SURGERY BUTTON-SCREW TECHNIQUE SURGERY THE FASTTHREAD CREW BROKE WHILE INSERTING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035715 ↗
• MalfunctionDec 12, 2024Break; Break

  ON 11/14/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-4030C-09 SCREW WAS INSERTED TO FIX THE GRAFT TO THE TIBIA AND IT BROKE. THE DOCTOR CHOSE NOT TO DRILL IT, EVEN THOUGH HE USED 1 NUMBER LARGER THAN THE DRILL USED TO MAKE THE TUNNEL (TUNNEL 8 AND SCREW 9). AFTER REMOVING ALL THE FRAGMENTS FROM THE PATIENT, HE SCREWED IN A NEW SCREW OF THE SAME SIZE AS THE PREVIOUS ONE. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919335 ↗
• MalfunctionSep 23, 2024Break; Break

  ON 09/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4030C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THE CASE WAS COMPLETED BY REMOVING THE SCREW, AND ADDITIONAL FIXATION WAS PLACED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20280174 ↗
• InjurySep 20, 2024Break; Break

  IT WAS REPORTED THAT 4 MONTHS AFTER THE SURGERY THE DEVICE BROKE POSTOPERATIVE AND DISLOCATED. THE PART OF THE SCREW REMAINED IN THE FREE JOINT BODY AND WILL BE REMOVED DURING REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 20270052 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE IMPLANT BROKE OFF WHILE SCREWING INTO THE BONE. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831048 ↗
• MalfunctionJul 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE IMPLANT BROKE WHILE SCREWING INTO THE BONE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785175 ↗
• MalfunctionMay 9, 2024Break; Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN (B)(6) SCREW BROKE DURING INSERTION. THIS OCCURRED DURING AN ACL RECONSTRUCTION. IT STAYED IN ONE PIECE AND REMAINED ON THE DRIVER. THE IMPLANT NEVER ENTERED THE PATIENT. IT WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19282288 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE IMPLANT BROKE WHILE SCREWING INTO THE BONE. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18770496 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW BROKE WHILE SCREWING INTO THE BONE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100958 ↗
• InjurySep 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE GRAFT BROKE IN THE JOINT BECAUSE THE SCREW MIGHT HAVE BEEN TOO SHARP. THE BROKEN GRAFT WAS RETRIEVED FROM PATIENT. THE SURGERY COULD NOT BE COMPLETED BECAUSE THE GRAFT BROKE, SO A SECOND SURGERY WILL BE PERFORMED ON (B)(6) 2023. UPDATE (B)(6) 2023 NROEMER: FURTHER INFORMATION REVEALED THAT WHEN THE GRAFT WAS IMPLANTED THE SURGEON CHECKED THE TENSION AND DISCOVERED THAT THE GRAFT WAS LOOSE. WHEN THE SURGEON PULLED ON THE GRAFT, IT CAME ALONG UP/IN THE JOINT. THE SCREW AND THE PART THAT WAS IN THE TIBIA TUNNEL WERE COMPLETELY REMOVED. THE REST OF THE GRAFT IN THE JOINT AND THE FEMUR TUNNEL WAS SHAVED AWAY. AN ACL BUTTON FROM AR-1588RT IS STILL IN THE PATIENTS LATERAL. THE QUADRUPLE SEMI T AND GRACILIS GRAFT WAS FIXATED WITH AN ACL TIGHTROPE (AR-1588RT) AT THE PROXIMAL PART OF THE GRAFT AND ALSO SUTURED DISTAL WITH SUTURETAPE (AR-7500). THE DISTAL PART OF THE GRAFT WAS FIXATED WITH AR-4030C-09.

  Patient problems: Failure of Implant

  MAUDE report 17714221 ↗